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A randomized multicenter clinical evaluation of sequential application of 0.3% and 0.15% hyaluronic acid for treatment of dry eye

  • Clinical Investigation
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Abstract

Purpose

We report the clinical efficacy of sequential applications of 0.3% and 0.15% unpreserved hyaluronic acid (HA) for the treatment of dry eye disease (DED).

Study design

Randomized clinical trial.

Methods

Patients over 19 years of age with DED level 2 or higher, corneal fluorescein staining (CFS) score > 1, and tear break-up time (TBUT) < 10 s were included. Seventy-six patients were randomly assigned to the 0.15% HA group, 0.3% HA group, or combination group. Each group applied two drops of 0.15% or 0.3% HA, or a single drop of both 0.3% and 0.15% HA. Patients were evaluated using the ocular surface disease index (OSDI), CFS and conjunctival fluorescein stain score, TBUT, and blurring/discomfort after application at baseline, 4 weeks, and 8 weeks.

Results

The combination group had the greatest improvement in CFS score from baseline to 8 weeks, compared with the 0.15% and 0.3% HA group (p < 0.001). The combined CFS-OSDI responder rates of the combination group (CFS score = 0 and OSDI ≥ 50% improvement at 8 weeks) were significantly higher than those of the 0.15% and 0.3% groups (p = 0.037). At 4 and 8 weeks, blurring after application in both the 0.3% and combination groups was significantly higher than in the 0.15% group, despite no difference between the 0.3% and combination groups. There were no differences in CFS and conjunctival staining score, TBUT, or OSDI within the three groups at baseline, 4 weeks, and 8 weeks.

Conclusions

Sequential application of 0.3% and 0.15% HA improved symptoms/signs in moderate to severe DED patients.

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Acknowledgements

This work was equally supported by the National Research Foundation of Korea (NRF) grant funded by the Korean government (MSIT) (No. 2021R1A2C2013939 and 2021R1C1C1011528).

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Correspondence to Hong Kyun Kim.

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J. H. Jun, None; S. P. Bang, None; H. S. Park, None; D. Yoon, None; J. Y. Ahn, None; S. J. Kim, None; H. K. Kim, None.

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Corresponding Author: Hong Kyun Kim

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Jun, J.H., Bang, S.P., Park, H.S. et al. A randomized multicenter clinical evaluation of sequential application of 0.3% and 0.15% hyaluronic acid for treatment of dry eye. Jpn J Ophthalmol 66, 58–67 (2022). https://doi.org/10.1007/s10384-021-00885-x

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  • DOI: https://doi.org/10.1007/s10384-021-00885-x

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